Your Health News at BAMI.us

OTC Weight-Loss Drugs Exposed by the FDA

Today’s store shelves are lined with weight-loss products containing undeclared and potentially unsafe active ingredients, according to recent findings by the FDA.   Marketed as “dietary supplements” that claim to be “natural” or contain only “herbal” ingredients, many of the over-the-counter, weight-loss products found in America’s local health food stores, beauty salons, as well as grocery and drug stores, illegally contain potentially dangerous prescription drugs such as antidepressants, diuretics, antiseizure drugs and appetite suppressants, according to the FDA. 

Recently, the FDA has recalled 72 of these products which contain the following illegal ingredients:

• sibutramine (An appetite  suppressant, sibutramine works by increasing the activity of certain chemicals, called norepinephrine and serotonin, in the brain. The FDA found sibutramine in many products at levels much higher than the maximum daily dosage for the prescription drug, Meridia, the only FDA-approved drug product containing sibutramine. Especially at excessive doses, sibutramine can have many serious side effects such as high blood pressure, increased heart rate, cardiac arrhythmias, seizures, rapidly changing moods, anxiety and depression),
• phenolphthalein (has been a common active ingredient in laxatives but is now being removed from the market because of concerns over carcinogenicity).
• fenproporex (a stimulant which is an amphetamine derivative, used as an appetite suppressant),
• fluoxetine (Prozac, a prescription antidepressant),
• bumetanide (Bumex, a strong prescriptions diurectic which can cause a lethal electrolyte imbalance if not monitored),
• furosemide (Lasix, a strong prescription diuretic which can cause a lethal electrolyte imbalance if not monitored),
• rimonabant (an appetite suppressant which is illegal in the U.S. because of the risk of serious neurological disease such as severe psychiatric problems and even suicide. It is also thought to promote the development of neurodegenerative diseases of the central nervous system such as Multiple sclerosis, Alzheimer’s disease, Amyotrophic lateral sclerosis (ALS), Parkinson’s disease, and Huntington’s disease)
• cetilistat (an investigational drug, similar to orlistat)
• phenytoin (Dilantin, antiseizure drug), and

Potential health risks posed by the tainted products include high blood pressure, seizures, tachycardia, palpitations, lethal electrolyte imbalances, heart attack, stroke, severe psychiatric problems, suicide and cancer.

The FDA recall began in December of 2008 with 25 products, and the FDA said it will continue to update the list as necessary. As of March 20, 2009 the following drugs have been recalled by the FDA:

• 2 Day Diet — sibutramine
• 2 Day Diet Slim Advance — sibutramine
• 2x Powerful Slimming — sibutramine
• 3 Day Diet — sibutramine
• 3 Days Fit — sibutramine
• 3x Slimming Power — sibutramine, phenytoin
• 5x Imelda Perfect Slimming — sibutramine
• 7 Day Herbal Slim — sibutramine
• 7 Days Diet — sibutramine
• 7 Diet — sibutramine
• 7 Diet Day/Night Formula — sibutramine
• 8 Factor Diet — sibutramine, phenolphthalein
• Eight Factor Diet — sibutramine
• 21 Double Slim — sibutramine
• 24 Hours Diet — sibutramine, phenolphthalein
• 999 Fitness Essence — sibutramine
• BioEmagrecim — fenproporex, fluoxetine, furosemide
• Body Creator — sibutramine
• Body Shaping — sibutramine
• Body Slimming — sibutramine
• Cosmo Slim — sibutramine
• Extrim Plus — sibutramine, phenytoin
• vExtrim Plus 24 Hour Reburn — sibutramine
• Fasting Diet — sibutramine
• Fatloss Slimming — sibutramine, phenolphthalein
• GMP — sibutramine
• Herbal Xenicol — cetilistat
• Imelda Fat Reducer — sibutramine
• Imelda Perfect Slim — sibutramine, phenolphthalein
• JM Fat Reducer — sibutramine
• Lida DaiDaihua — sibutramine
• Meili — sibutramine
• Meizitang — sibutramine
• Miaozi MeiMiaoQianZiJiaoNang — sibutramine
• Miaozi Slim Capsules — sibutramine
• Natural Model — sibutramine
• Perfect Slim — sibutramine
• Perfect Slim 5x — sibutramine, phenolphthalein
• Perfect Slim Up — sibutramine
• Phyto Shape — rimonabant
• Powerful Slim — sibutramine
• ProSlim Plus — sibutramine
• Reduce Weihgt — sibutramine
• Royal Slimming Formula — sibutramine, phenolphthalein
• Sana Plus — sibutramine
• Slim 3 in 1 — sibutramine
• Slim 3 in 1 Extra Slim Formula — sibutramine
• Slim 3 in 1 Extra Slim Waist Formula — sibutramine
• Slim 3 in 1 M18 Royal Diet — sibutramine
• Slim 3 in 1 Slim Formula — sibutramine
• Slim Burn — sibutramine
• Slim Express 4 in 1 — sibutramine
• Slim Express 360 — sibutramine
• Slim Fast — sibutramine
• Slim Tech — sibutramine
• Slim Up — sibutramine
• Slim Waist Formula — sibutramine
• Slim Waistline — sibutramine
• Slimbionic — sibutramine
• Sliminate — sibutramine
• Slimming Formula — sibutramine
• Somotrim — sibutramine
• Starcaps — bumetanide
• Super Fat Burner — sibutramine
• Superslim — sibutramine, phenolphthalein
• Super Slimming — sibutramine
• Trim 2 Plus — sibutramine
• Triple Slim — sibutramine
• Venom Hyperdrive 3.0 — sibutramine
• Waist Strength Formula — sibutramine
• Xsvelten — sibutramine
• Zhen de Shou — sibutramine, phenolphthalein

The herbal market is a booming, and rapidly growing, multimillion dollar industry yet many herbal manufacturers make false claims regarding the effectiveness of their products. Just because it’s advertised on the radio, TV or available on the store shelf, doesn’t mean that it’s safe.  There are no Federal quality controls for herbal and dietary supplements and there is a lack of consistency in dose and quality of many products that appear on the market. In other words, the label may not necessarily match the ingredients. Furthermore, most herbs and supplements have not been thoroughly tested for safety or interactions with other herbs, supplements, drugs, or foods.

The only legal OTC weight-loss product is called “Ally”.  Approved by the FDA in 2007, the active ingredient in Ally is orlistat and it helps produce weight loss by decreasing the intestinal absorption of fat. Xenical, the prescription version, was initially approved in 1999 as a drug to treat obesity, and remains on the market at twice the dose of the OTC version.

Even though orlistat (Ally) is over-the-counter and approved by the FDA, it’s important to be aware that it has significant potential side effects and can be unsafe for certain people. Fat that isn’t absorbed passes through the digestive system, causing abdominal pain, loose stools, oily flatulence, and even mild incontinence in some patients, depending on how well users comply with a low-fat diet. Also, people taking orlistat showed mild but consistent deficiencies of vitamins A, E, and beta-carotene. The drug’s label is expected to include recommendations that users take a daily multivitamin. Orlistat can also lead to hepatitis, gallstones and kidney stones. It is not for people who have problems absorbing food, or for those who have had organ transplants. Also, anyone taking blood-thinning medicines or being treated for diabetes or thyroid disease should consult a physician before using orlistat.

Despite all the research and intense motivation to find a safe diet pill, the miracle drug remains to be found.  There is no substitute for regular exercise and a reduced-calorie, low fat diet.

Read about starting an exercise program

Source: FDA
Source: MedPage Today, March 20, 2009

Bookmark this page
E-mail this story
 Print this post